NCT04198831已完成不适用
Effect of Acupuncture on Quiescent Crohn's Disease
Shanghai Institute of Acupuncture, Moxibustion and Meridian1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- The proportion of clinical relapse rates
研究概览
简要总结
To observe the clinical effect of acupuncture on quiescent Crohn's disease
详细描述
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 16-70;
- •Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
- •Patients with more than 2 disease relapses in the past year;
- •patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
- •those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
- •those who have never experienced acupuncture;
- •patients signing informed consent.
排除标准
- •patients who are recently pregnant or in pregnancy or lactation;
- •patients with serious organic diseases;
- •patients diagnosed as psychosis;
- •patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
- •severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
- •there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
- •patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
- •there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
结局指标
主要结局
The proportion of clinical relapse rates
时间窗: Week 48
Defined as a CDAI score of \>150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
次要结局
- The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)(Week 12 and 24)
- Number of relapses(Week 48)
- Time of first relapse(Week 48)
- Moderate to severe clinical relapse rate(Week 48)
- The mean change of serum CRP level from baseline(Week 12, 24, 36 and 48)
- The mean change of CDAI from baseline(Week 12, 24, 36 and 48)
- The mean change of the Hospital anxiety and depression scale (HADS)(Week 12 and 24)
- The mean change of Crohn's disease endoscopic index of severity (CDEIS)(Week 48)
研究者
研究点 (1)
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